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Axial SpondyloarthritisSatiSpActionNCT03965650

Video Coaching of Physical Activity in Axial Spondyloarthritis

A study testing Video coaching exercises and Routine exercises in people with Axial Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The primary objective of the study is to demonstrate the beneficial effect of a 3 months home-based physical exercise program supervised by online videos, in addition to the usual recommendations, in comparison with usual physical activity as recommended by the WHO. The secondary objectives of the study are : 1. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Axial Spondyloarthritis
What is being tested?
Video coaching exercises and Routine exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteFrance
Study dates
24 Feb 2022to 13 Aug 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient between 18 and 65 years;
  • Patient can read and understand French;
  • Signed informed consent form to participate in the study;
  • Axial spondylarthritis according to ASAS criteria;
  • Patient with a BASDAI score between 2.5 and 5;
  • No change of biotherapy anti-TNF or anti-IL17 during the 3 months preceding the inclusion;
  • Patient equipped with an internet access;
  • Medical certificate of proposed physical activities.

Who cannot join

  • All diseases (cardiovascular disease or chronic neurological disease or others) contraindicating the requested exercises according to physician;
  • Axial spondyloarthritis in remission defined by a BASDAI < 2.5/10 or in excessive inflammatory activity, defined by BASDAI > 5/10;
  • Pregnant woman (positive pregnant test) or woman try to conceive in following 6 months;
  • Patient with articular prosthesis;
  • Patient who already participate in a specific exercise program or practice a sport (including Yoga or Tai Chi) more than one hour per week;
  • Severe obesity ( BMI > 35);
  • Patient without health insurance;
  • Patient legally unable.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Service de rhumatologie, Hôpital Ambroise Paré

    Boulogne-Billancourt, Hauts-de-Seine, 92100

Other trials in France

About this study

Official title: Randomized Controlled Study of a Video Coaching Program of Physical Activity in Patients Suffering From Axial Spondyloarthritis

The primary objective of the study is to demonstrate the beneficial effect of a 3 months home-based physical exercise program supervised by online videos, in addition to the usual recommendations, in comparison with usual physical activity as recommended by the WHO.

The secondary objectives of the study are :

  1. to compare the following criteria between 2 groups at 3 and 6 months:
  • quality of life;
  • other measures of disease activity ;
  • sleep quality ;
  • walking ability
  • muscle strength of;
  • professional activity;
  • cost of cares;
  • evolution of weight, BMI and waist.
  1. to evaluate the observance of physical activity program and its tolerance at 3 and 6 months.
Read the detailed description

The spondyloarthritides are a group of inflammatory rheumatic diseases, including ankylosing spondylitis, reactive arthritis, inflammatory bowel disease-related rheumatic disease, and psoriatic arthritis.

The frequence of axial spondyloarthritis is 0.41% in the french population. This disease is associated with a reduction of physical capacities and quality of life. NSAIDs or even biologic therapies do not always permit a sufficient control of the disease. Different physical exercise programs can be effective as an additional therapy for spondyloarthritis, with positive effects on spinal mobility as well as main disease activity and functional indices (BASDAI, BASFI and BASMI). The severity of the disease does not seem to influence significantly the patients' motivation in practicing physical activity.

This proposed study aims to demonstrate the beneficial effect of physical exercises coached with a specific internet program diffused on a secured platform.

Each patient will have to connect 3 times weekly in order to follow the entire program.

The impact will be evaluated at 3 months and 6 months.

Potential impacts of video-coaching program are:

  • reduction of the intrinsic inflammatory activity of the rheumatic disease;
  • improvement of the global physical condition: muscular strength and resistance, walking ability, chest expansion;
  • reduction of fatigue and improvement of sleeping;
  • reduction of consumption of symptomatic drug (analgesics, NSAIDs, corticosteroids).
Being tested
Video coaching exercises, Routine exercises
Keywords
axial spondyloarthritis, online video coaching, physical activity
Medical subject headings
Axial Spondyloarthritis, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video coaching exercisesOther

    Patients will perform physical exercises following a specifical video coaching program during 6 months.

  • Routine exercisesOther

    Routine method by advising and encouraging patients to perform exercises according to the WHO recommendations during the first 3 months of the study.

    Thereafter, patients will have access to the video coaching program of physical activities during the following 3 months.

Study groups in NCT03965650
Study groupRoleWhat they receive
Intervention group: video coaching exercisesExperimentalVideo coaching exercises group: patients will perform physical exercises according to a video coaching program 3 times weekly during 6 months. The on-line program has been designed especially for this study.
Receives: Other: Video coaching exercises
Control group: routine exercisesActive comparatorRoutine method advising and encouraging patients to perform physical activities according to the WHO recommendations during 3 months then to follow the video coaching physical exercises program during 3 months.
Receives: Other: Routine exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients responding to the "ASAS 20" criterion at 3 months

    The primary outcome measure will be the proportion of patients simultaneously satisfying both criteria :

    • at least 20% improvement
    • improvement of at least 10 points on visual analog scale in the following domains: overall evaluation by the patient, visual analog scale (pain scale), Bath Ankylosing Spondylitis Functional Index (BASFI), and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).

    Measured: at 3 months

Secondary outcomes (15)

  1. Ankylosing Spondylitis Disease Activity : (BASDAI) (PRO)

    Ankylosing Spondylitis Disease Activity will be assessed with the Bath Ankylosing Spondylitis Disease Activity (BASDAI) auto-questionnaire assessing the inflammatory activity of the disease.

    Measured: at baseline, 3 months and 6 months

  2. Ankylosing Spondylitis Disease Activity : (ASDAS CRP) (PRO)

    Ankylosing Spondylitis Disease Activity will be assessed with the Ankylosing Spondylitis Disease Activity Score (ASDAS CRP) auto-questionnaire assessing the inflammatory activity of the disease.

    Measured: at baseline, 3 months and 6 months

  3. Bath Ankylosing Spondylitis Functional Index (BASFI) (PRO)

    Data collected with the Bath Ankylosing Spondylitis Functional Index (BASFI) auto-questionnaire assessing the functional impact of disease.

    Measured: at baseline, 3 months and 6 months

  4. Fatigue (PRO)

    Fatigue will be assessed with a Visual Analogue Scale

    Measured: at baseline, 3 months and 6 months

  5. Health assessment: HAQ-S (PRO)

    SpA-related health will be assessed with the Health Assessment Questionnaire for the Spondyloarthropathies (HAQ-S)

    Measured: at baseline, 3 months and 6 months

  6. SPA impact on general health: ASAS-HI (PRO)

    General health will be assessed with the ASAS Health Index auto-questionnaire

    Measured: at baseline, 3 months and 6 months

  7. Work Productivity and Activity : WPAI (PRO)

    Work Productivity and Activity will be assessed with the Work Productivity and Activity Impairment (WPAI) auto-questionnaire

    Measured: at baseline, 3 months and 6 months

  8. Sleep quality: PSQI

    Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI) auto-questionnaire

    Measured: at baseline, 3 months and 6 months

  9. Physical activity: IPAQ (PRO)

    Physical activity will be assessed with the International Physical Activity Questionnaire (IPAQ) - Short Form and Long Form auto-questionnaires

    Measured: at baseline, 3 months and 6 months

  10. Analgesic and anti-inflammatory drug intake

    Following drugs intake will be collected:

    • non-steroidal anti-inflammatory drugs (NSAIDs)
    • corticosteroids

    Measured: at 3 months and 6 months

  11. Anthropometric measures: BASMI

    The functional impact of SpA will be assessed with the Bath Ankylosing Spondylitis Metrology Index (BASMI)

    Measured: at baseline, 3 months and 6 months

  12. Anthropometric measures: Enthesitis: MASES

    Entesis involvement will be assessed with the Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

    Measured: at baseline, 3 months and 6 months

  13. Anthropometric measures: Muscle strength: dynamometer

    Muscle strength of the upper and lower limbs will be assessed with a dynamometer

    Measured: at baseline, 3 months and 6 months

  14. Anthropometric measures: 6-minutes walk test

    Walking ability will be assessed with the 6-minutes walking test.

    Measured: at baseline, 3 months and 6 months

  15. Anthropometric measures: Body mass index (BMI)

    Weight, height and waist size will be collected to calculate the BMI of patients.

    Measured: at baseline, 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2019
  2. Study start24 Feb 2022
  3. Primary completion13 Aug 2026 (estimated)
  4. Study completion13 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03965650
Sponsor's protocol ID
APHP190622
Other IDs
2019-A01384-53
Acronym
SatiSpAction
Status last verified
Jul 2026
First submitted
24 May 2019
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Video coaching exercises and Routine exercises in people with Axial Spondyloarthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients responding to the "ASAS 20" criterion at 3 months (time frame: at 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03965650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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